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Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial. (GAP)

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ClinicalTrials.gov Identifier: NCT02280031
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

Brief Summary:
Low-dose aspirin started in the first-trimester has been associated with a decrease of preeclampsia, fetal growth restriction and preterm birth in high-risk pregnancies. Multiple pregnancies are considered a risk factor for all those adverse outcomes. The main objective of the current trial is to evaluate whether a dose of 80 mg of aspirin is associated with an improvement of birthweight compared to placebo in twin pregnancies.

Condition or disease Intervention/treatment Phase
Small for Gestational Age Infant, Very Low Birth Weight Fetal Growth Retardation Preeclampsia Premature Birth Drug: Acetylsalicylic Acid Drug: Placebo Phase 2

Detailed Description:

Twin pregnancies represent approximately 3% of births and are associated with increased risks of complications such as preeclampsia, fetal growth restriction and preterm birth. All of these complications are commonly associated impaired placental function and low birth weight.

Most prophylactic measures tested over the years have failed to prevent these adverse outcomes in twin pregnancies. Since administration of low-dose of aspirin can improve placental function and all these adverse outcomes in high-risk pregnancies, mainly in women with prior adverse outcomes, we suggest that similar benefits could be seen in twins. We are expecting that the administration of low-dose of aspirin starting in the first-trimester in twin pregnancies could lead to an improvement of placental function, a reduction or these adverse perinatal outcomes and therefore to an improvement of birthweight.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial
Study Start Date : November 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight
Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Experimental
Acetylsalicylic Acid 80mg administered daily at bedtime
Drug: Acetylsalicylic Acid
Capsule containing Acetylsalicylic Acid 80mg pill with lactose
Other Names:
  • Aspirin
  • ASA
  • Asaphen

Placebo Comparator: Control
Identical placebo administered daily at bedtime
Drug: Placebo
Capsule containing placebo pill with lactose
Other Name: Control




Primary Outcome Measures :
  1. Birth weight [ Time Frame: At delivery ]

Secondary Outcome Measures :
  1. Low birth weight [ Time Frame: At delivery ]
    (birthweight below 2,500 grams)

  2. Very low birth weight [ Time Frame: At birth ]
    (birthweight below 1,500 grams)

  3. Fetal growth restriction [ Time Frame: 16-18 and 22-24 weeks ]
    (birthweight below the 10th or 3rd percentile for gestational age)

  4. Preterm birth [ Time Frame: At delivery ]
    (delivery before 37 weeks)

  5. Very preterm birth [ Time Frame: At delivery ]
    (delivery before 34 weeks)

  6. Preeclampsia [ Time Frame: At delivery ]
    (according to American College of Obstetricians and Gynecologists 2014 guidelines definition)

  7. Early-onset preeclampsia [ Time Frame: At delivery ]
    (onset of preeclampsia before 34 weeks)

  8. UtA_PI [ Time Frame: 22-24 weeks ]
    Mean uterine artery pulsatility index

  9. Aspirin resistance [ Time Frame: 16-18 and 22-24 weeks ]
    (PFA-100 below 150)

  10. Cervical length [ Time Frame: 22-24 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gestational age between 8 0/7 and 13 6/7 weeks
  • Twin pregnancy confirmed by ultrasound

Exclusion Criteria:

  • One or two negative heart beat
  • Previous hypertensive disorder of pregnancy
  • Pre-existing hypertension or diastolic blood pressure >90 mmHg at randomization
  • Pre-existing nephropathy
  • Pre-existing diabetes (type 1 or 2)
  • Anaphylactic allergy to lactose
  • Known coagulopathy (antithrombin III deficiency, factor V Leiden, antiphospholipid syndrome, the prothrombin mutation, deficiency of protein S or protein C)
  • Use of heparin or other anticoagulants.
  • Contre-indications to aspirin
  • Discordance of crown-rump length greater than 20%.
  • Fetal anomalies (cystic hygroma, nuchal translucency > 95th percentile, anencephaly, omphalocele, etc.)
  • Previous or current gastric ulcer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280031


Locations
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Canada
Hôpital St-François d'Assise-CHUQ
Quebec, Canada, G1L 3L5
Centre Hospitalier Universitaire de Québec (CHU de Québec)/Pavillon CHUL
Québec, Canada, G1V 4G2
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
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Principal Investigator: Emmanuel Bujold, MD,MSc,FRCSC CHU de Québec

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Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02280031     History of Changes
Other Study ID Numbers: 2014-1817
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: April 2016
Keywords provided by CHU de Quebec-Universite Laval:
Twin Pregnancy
Pregnancy Complications
Additional relevant MeSH terms:
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Aspirin
Pre-Eclampsia
Premature Birth
Fetal Growth Retardation
Birth Weight
Body Weight
Signs and Symptoms
Hypertension, Pregnancy-Induced
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics